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The whole point of SCINetChina was to be able to run clinical trials quickly and cost effectively and accelerate or fast fail therapies.

In your opinion how has SCINetChina accelerated the process if we have to still run these three groups in the (more expensive setting of) US in order to know what may or may not work for chronic SCI?

Enlighten me please Jim?

Those are goals of all of our clinical trial networks. Unfortunately, reality on the ground doesn't always allow it to happen.

After the ChinaSCINet Phase II was completed, China decided they would not allow cells from outside to be imported and used in clinical trials. This hung up ChinaSCINet for close to 2 years. They have since reversed course (after Taiwan decided to conduct our Phase IIB). Before that, 8 clinical trials were conducted for less that $2 million.

In order for this treatment to be approved in the US, it must be done here. The goal is worldwide approval, so the IIB Trials will also be conducted in Taiwan and India. This is the way this treatment, and future ones, will reach as many people as possible.

Those are goals of all of our clinical trial networks. Unfortunately, reality on the ground doesn't always allow it to happen.

After the ChinaSCINet Phase II was completed, China decided they would not allow cells from outside to be imported and used in clinical trials. This hung up ChinaSCINet for close to 2 years. They have since reversed course (after Taiwan decided to conduct our Phase IIB). Before that, 8 clinical trials were conducted for less that $2 million.

In order for this treatment to be approved in the US, it must be done here. The goal is worldwide approval, so the IIB Trials will also be conducted in Taiwan and India. This is the way this treatment, and future ones, will reach as many people as possible.

I am still a little bit confused. ChinaSCINet tested a combination therapy (UCB+Li+intensive walking), collated and published the data. It has been decided the therapy is efficacious enough to roll out in 3 other countries, including the United States. However, it appears that the US trial protocol requires the testing of each component of the combination - ie 3 cohorts.

What is the logic of now using the more expensive trial network in the US to test each of the combination components individually. How has ChinaSCINet benefited the overall timeline or budget?

From a timeline and budget perspective, all I see is that we are incurring the same trial cost that we would have incurred if we started out with a US-based clinical trial some 10 years ago plus the cost of spinning up ChinaSCINetwork and a gazillion airmiles between NJ and Kunming.

I am still a little bit confused. ChinaSCINet tested a combination therapy (UCB+Li+intensive walking), collated and published the data. It has been decided the therapy is efficacious enough to roll out in 3 other countries, including the United States. However, it appears that the US trial protocol requires the testing of each component of the combination - ie 3 cohorts.

What is the logic of now using the more expensive trial network in the US to test each of the combination components individually. How has ChinaSCINet benefited the overall timeline or budget?

From a timeline and budget perspective, all I see is that we are incurring the same trial cost that we would have incurred if we started out with a US-based clinical trial some 10 years ago plus the cost of spinning up ChinaSCINetwork and a gazillion airmiles between NJ and Kunming.

In 1998 the Goodwill Games were held in New York City. Chinese gymnast, Sang Lan, broke her neck while practicing vaults. Her parents flew in from China and came here to meet with Wise to see if anything could be done. The family stayed here for several months while Sang attending Mount Sinai for rehabilitation. At a going away party before heading back to China, Sang was upset and asked Wise how she could be involved when he discovered a treatment in the US. He said the the only way would be to have clinical trials in China, and promised to try and make it happen. Soon after he traveled to China for the first time in his life and began to organize ChinaSCINet.

That is how ChinaSCINet came about.

I would encourage those who are unfamiliar with the beginning, to go back to read this thread from page 1. Post #14 explains why UCB and lithium were chosen for the 1st therapy.

FPF,

UCB+Li+intensive walking wasn’t a treatment group in the ChinaSCINet trial. The only group that took lithium also received methylprednisolone, therefore we do not know if lithium+cells+walking will be better than cells+walking. If lithium is not beneficial in the IIb trials, it will not be included in phase III.

This therapy could not have been done in the U.S. ten years ago. First, many more animal experiments would have had to be completed, and second, to my knowledge, no American neurosurgeon had ever injected cells into a human spinal cord. There’s no way this would have been approved. Chinese neurosurgeons had been opening the dura and injecting cells for many years. There was no risk in their eyes.

Wise was tired of waiting and believed it was time to go ahead with the most promising human therapy. He and all the top scientists/neurosurgeons in China held a consensus conference and decided UBC + lithium was the way to go. The surgery was 100% safe, and recovery was much more robust than expected.

He has traveled nearly 2 million miles since the early 2000’s because in his eyes, that’s what was necessary to get these clinical trial networks set up in order to test the most promising therapies coming down the pipeline. The foundation’s have been laid, now there are 4 more legitimate clinical trial networks to test therapies. They will become more efficient and effective with experience. Each country is paying their own costs. Wise pays for his own travel expenses.

Jim,
Encouraging umbilical cord blood and tissue donation seems like such an easy way to provide stem cells for many, for research and for personal use. Do you know if flexible spending accounts, health savings accounts, etc. can pay if it is the brother of the mother for potential clinical trials or compassionate use in the near future?

Hey Jim, I believe Wise has stated that the returned walking was all due to CPG and that the patients couldn't actually lift their legs if lying down; in bed for example. Was this true even for the 4 patients of the 20 that advanced to the 4 point walkers? Also in regards to the CPG and walking, how does stepping get initiated, in lets say those with 4 point walkers?

Letter of Medical Necessity for storing umbilical cord and blood for transplant

How difficult will it be to get an LMN to allow for Health Savings Account tax credit if you have a spinal cord injury and would like to be able to store a cord now for use in clinical trials?

My thought is that organ transplants are done with multiple families and multiple organs, so why not a type of swapping, which may allow matched stem cells, etc. from umbilical cord blood and tissue to be swapped to help the greater SCI population, at some point. With that in mind, family umbilical cord blood and tissue donations may increase. I don't think folks have a real sense of the potential benefits. Looks like congress has turned this down, but perhaps there hasn't been enough pressure from enough people familiar with a more universal benefit? The cost is an issue, but folks may see this as a way to help cut medical costs

Jim,
Encouraging umbilical cord blood and tissue donation seems like such an easy way to provide stem cells for many, for research and for personal use. Do you know if flexible spending accounts, health savings accounts, etc. can pay if it is the brother of the mother for potential clinical trials or compassionate use in the near future?

You should contact StemCyte, they probably have experience with that.

Originally Posted by Barrington314mx

Hey Jim, I believe Wise has stated that the returned walking was all due to CPG and that the patients couldn't actually lift their legs if lying down; in bed for example. Was this true even for the 4 patients of the 20 that advanced to the 4 point walkers? Also in regards to the CPG and walking, how does stepping get initiated, in lets say those with 4 point walkers?

One of the best walkers is able to go long distances with a four point walker, but when laying down on his side, can barely move his legs. It really shows how walking is a programmed function. In order to regain muscle function, I think it will be necessary to exercise each one to re-establish connections. The Phase IIb is going to teach us a lot. Hopefully the participants will regain hand/finger function.

One of the best walkers is able to go long distances with a four point walker, but when laying down on his side, can barely move his legs. It really shows how walking is a programmed function. In order to regain muscle function, I think it will be necessary to exercise each one to re-establish connections. The Phase IIb is going to teach us a lot. Hopefully the participants will regain hand/finger function.

Tommy, what say you?

Hey Jim, I'm assuming you're asking me...so here's my educated guess of an answer that contains some theoretical information.
When walking, a step must be voluntarily initiated by the brain - you have to decide to move your leg to walk. However, the decision "I want to take a step" is different than voluntarily deciding "I want to shift weight on to one leg...now I want to flex my hip and extend my ankle simultaneously...now I want to flex my ankle while driving forward off my stance leg...now I want to bring my weight more medial..." (and on goes the extensive list of highly coordinated muscle actions that walking requires). Jim mentioned how walking is "programmed" - once you voluntarily decide to walk, all you really have to think about is "I want to keep walking" and CPGs - autopilot in the brainstem and spinal cord, essentially, handles the rest of the movements. For those CPG "autopilots" to be activated, we likely need more than just a decision from the brain - we need to be in an upright position, getting appropriate sensory feedback from our body, especially the bottoms of our feet - lots of work dating back to the 70's and 80's from Gerasimenko, Rossignol, Edgerton etc. have shown us this.

In the early 2000's Harkema and others published a paper showing that some people with incomplete SCI could activate large groups of muscles in their legs when attempting movements involving multiple joints, like attempting to stand or do a leg press. However, when asked to activate individual muscles or move one joint at a time, they couldn't do it. This again shows evidence that many movements are not only "programmed", but some are controlled by different spinal cord tracts, or parts of the brain entirely.

So, if you take a healthy, mature nervous system, injure it and let it re-organize (as happens in chronic SCI), inject something into it to give it a chance to grow (UMBC) and train the nervous system (walking training) to get the nervous system to re-organize AGAIN, you get the perplexing results that Wise Young et al. have found so far

I would imagine that voluntary function (moving the legs in bed, or fingers, for instance) may have been better in the initial cohort if they had devoted less time to walking and more time to training movement in individual joints/muscles, but that is solely a guess of mine.